Sleep Disturbances, Postoperative Discomfort, Heart Valve Diseases
Conditions
Keywords
Virtual Reality, Binaural Beat Stimulation, Cardiac Surgery, Mechanical Heart Valve, Sleep Quality, Patient Discomfort
Brief summary
This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery. Many patients experience sleep disturbances and discomfort due to the sound of the mechanical valve. Participants will be randomly assigned to one of two non-drug interventions to see which method improves sleep and reduces discomfort after surgery. The study aims to help improve recovery and comfort for patients after valve replacement.
Detailed description
This randomized clinical trial will evaluate the effects of four interventions on sleep disturbances and patient discomfort in adult patients after prosthetic mechanical valve replacement. Sleep disturbances are common due to the sound of the mechanical valve. Participants will be randomly assigned to one of four groups: (1) VR Group (2) Binaural Beat Group listening to binaural beats for 20 minutes (3) VR + Binaural Beat Group combining both interventions, and (4) Control Group receiving standard postoperative care without interventions. Primary outcomes include sleep quality and patient-reported discomfort measured during the early postoperative period. The study aims to identify which intervention or combination is most effective in improving recovery and patient comfort.
Interventions
BEHAVIORALVirtual Reality Relaxation
Guided VR relaxation sessions to reduce discomfort an enhance sleep quality
BEHAVIORALBinaural Beat Stimulation
Guide sessions BBS to reduce discomfort and enhance sleep quality
BEHAVIORALVR + Binaural Beat Group
Combined VR \& BBS sessions
Usual postoperative care for patients
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Not applicable - study is open label; all participants and staff are aware of the interventions.
Intervention model description
1. VR Group - receiving a Virtual Reality relaxation sessiones. 2. Binaural Beat Group - receiving a Binaural Beat Stimulation sessions. 3. VR + Binaural Beat Group - receiving both interventions. 4. Control Group - receiving standard postoperative care without interventionsز Randomization ensures that each participant has an equal chance of being assigned to any group, and all groups are followed concurrently to compare outcome.
Eligibility
Sex/Gender
ALL
Age
28 Years to 71 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be eligible for participation following mechanical valve replacement surgery if they are willing to participate, able to provide informed consent, and meet the following criteria: male or female aged 18 years or older, hemodynamically stable, oriented and conscious without cognitive impairment, free from visual or auditory impairments, able to communicate orally in Arabic, not receiving analgesics or sedatives within at least four hours prior to the intervention, and having no history of epilepsy, seizure disorders, or recurrent migraines.
Exclusion criteria
* The study's
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Discomfort | From postoperative day 3 until discharge from the cardiac surgery ward | Patient-reported discomfort measured using the Kolcaba Verbal Rating Comfort Scale (KCS), assessing the intensity of postoperative discomfort following prosthetic mechanical valve replacement. This measure captures the level of discomfort experienced by the patient during hospitalization that result from mechanical valve sound. |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORWaffa AR Hattab, Ph.D.
University of Baghdad, College of Nursing
Outcome results
None listed